Data / Medical devices / Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (OBT): 19 FDA-registered makers in 6 countries
19 establishments in 6 countries are registered with the FDA to make Plate, Bone, Growth Control, Pediatric, Epiphysiodesis (product code OBT, Class 2, 21 CFR 888.3030). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on October 24, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OBT
- Device class
- 2
- Regulation
- 888.3030
- Medical specialty
- Orthopedic
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 3 |
| China | 2 |
| Italy | 1 |
| Canada | 1 |
| Taiwan | 1 |
Makers of Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Orthofix SRL | BUSSOLENGO Verona, Italy | Manufacturer | 4 | May 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Manufacturer for export, Repackager or relabeler, Specification developer | 4 | May 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Orthopediatrics Canada ULC | Laval Quebec, Canada | Manufacturer | 1 | October 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Red Star Contract Manufacturing Inc. | Larwill, IN, United States | Complaint file establishment, Manufacturer | 1 | June 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Avalign Integrated Medical Solutions, Inc | Mentor, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aristotech Industries GmbH | Berlin, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fort Wayne Metals Research Products, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Klappenecker GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merete GMBH | Berlin, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syntec Scientific Corp. | CHANG HUA Changhua, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.